Kornimate/medical-research-clean huggingface dataset:
efficacy of adding azithromycin to cephalosporin before cesarean delivery

Conditions: Wound Sepsis

Summary: efficacy of adding azithromycin to cephalosporin before cesarean delivery

efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Eligibility criteria:
inclusion criteria: * age between 17 and 39 years * gestaional age between 37 to 42 weeks * elective cesarean delivery * obese women exclusion criteria: * diabetic women on corticosteroids * intraopertaive complication in previous section * history of septic woun * prelabour rupture of membrane \>12 hours
enhancing the vagal tone in prediabetes individuals

Conditions: Prediabetes; Autonomic Nervous System Imbalance; Poor Glycemic Control; Psychological Distress

Summary: this is a 2-year course of study. a randomized control trial will be conducted, in which 90 prediabetes individuals will be recruited and randomly assigned them into the wait-list control group or experimental group to test the effectiveness of 8 once-a-week, individual, 20-min sessions of hrv biofeedback on modulating vagal tone, glycemic control, psychological wellbeing, and inflammatory status in this population. its longitudinal effects will be evaluated after 3- and 6-month follow-up.

background. compared to healthy population, individuals with prediabetes have a higher risk to develop diabetes and other cardiovascular diseases. however, these downward progressions might positively associate with autonomic nervous dysfunction, especially low vagal tone, which can be detected prior to comorbidities confirmed. the significant correlations among low autonomic nervous, high psychological distress, inflammatory status, and poor glycemic regulation, which are regarded as the psychoneuroimmunological integration, have not been well studied in prediabetes individuals. heart rate variability (hrv) biofeedback is an easy and noninvasive intervention, which has been confirmed to strengthen baroreflex stimulation, facilitate the modulation of vagal tone, and further promote the physiological and psychological wellbeing in various diseases but not in prediabetes. objective. to test the effectiveness of hrv biofeedback on the modulating vagal tone and further enhancing the psychoneuroimmunological integration related to glycemic control, anti-inflammatory reaction, and psychological wellbeing. research methods. in this 2-year rct study, the investigators are planning to recruit 90 prediabetes individuals and randomly assigned them into wait-list control group or experimental group by using the random sequence of numbers generated from the excel bernoulli function. experimental group will receive 8 once-a-week, individual, 30-min sessions of hrv biofeedback and 1 session of healthy lifestyle education. during the biofeedback training period, subjects will be encouraged to self- home practice of resonant frequency breathing for 20 mins, twice-a-day. control group will receive 1 session of healthy lifestyle education. all subjects will be repeatedly assessed at time of enrollment, post-training (8 weeks after enrollment), 3-month, and 6-month follow-up. repeated assessments will include physiological measurements of hrv, bdnf, gas6, hba1c, crp, il- 6, fpg, and salivary cortisol, and psychological measurements of perceived stress, anxiety, and depression.

Eligibility criteria:
inclusion criteria: * aged 20 or more * fasting blood glucose level of 100 to 125 mg/dl * hba1c value of 5.7% to 6.4% exclusion criteria: * lack of chinese literacy * visual and hearing deficits * the presence of arrhythmia * previous diagnosed with diabetes * any other serious physical illness (e.g. severe neurocognitive disorders or evidence of cor pulmonale) or psychiatric disorders
probing the role of sodium channels in painful neuropathies

Conditions: Painful Peripheral Neuropathy; Painless Peripheral Neuropathy

Summary: neuropathic pain is a frequent feature of peripheral neuropathy causing a significant impact on patients' quality of life and health care costs. not all individuals with neuropathy develop pain and it is not possible to predict who is more or less susceptible among those with similar risk exposure. current inability to identify high-risk individuals hinders development and application of therapies to counteract neuropathic pain and to address targeted prevention strategies. recently, the investigators consortium has identified novel pathogenic mutations in genes encoding for two sodium channels (nav1.7 and nav1.8) known to play a critical role in the generation and conduction of action potentials in nociceptors and their terminal axons. this study was undertaken in a carefully selected group of patients with painful neuropathy using a candidate gene approach and directly revealed targets for new therapeutic strategies. this discover widened the spectrum of sodium channel-related pain disorders including conditions more common in the general population than those known so far. propane study, starting from the hypothesis of a common origin of neuropathic pain in a cohort of patients with predominantly small fibre neuropathy, aims to develop this original idea in a larger and well characterized study population, to provide evidence for the reliable stratification of patients at high risk and potential new treatments tailored on patients' clinical features, in order to improve their quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of sensory neuropathy, including pure small fibre neuropathy (sfn), based on established clinical, nerve conduction study (ncs) and skin biopsy findings (tesfaye et al. diab care 2010) caused by 1. type 1 or type 2 diabetes (world health organization criteria) with stable metabolic control for \>6 months (haemoglobin a1c \<9%); or 2. idiopathic aetiology after ruling out all known causes of neuropathy including vitamin deficiencies, malignancies, toxic, drugs exclusion criteria: * any other cause of neuropathy
nudging students towards healthy diet and physical activity to prevent obesity

Conditions: Obesity

Summary: the objective of the present study is to estimate the effect of nudging proposals on the students' body mass index, based on changes made in the school environment. this is a factorial randomized community trial, which will be conducted in 18 public schools in the city of duque de caxias, rj.


Eligibility criteria:
inclusion criteria: 5th and 6th grades students consent form signed by parents/tutors exclusion criteria: pregnant girls
a phase 1 trial of tst of pd 0332991 followed by cytarabine and mitoxantrone for adults with relapsed and refractory acute leukemias and high-risk myelodysplasia

Conditions: Relapsed Acute Leukemia; Refractory Acute Leukemia; High-Risk Myelodysplasia

Summary: 1.1 primary objectives * to determine the feasibility, tolerability, and toxicities of administering the selective cdk 4/6 inhibitor pd 0332991 prior to the combination of ara-c and mitoxantrone for adults with relapsed and refractory acute leukemias and high risk myelodysplasias (mds), including primary refractory disease * to determine the direct cytotoxic effects of single agent pd 0332991 on malignant blasts * to determine the maximal tolerated dose (mtd) of pd 0332991 in timed sequential combination with ara-c and mitoxantrone * to determine if the timed sequential combination of pd 0332991 with ara-c and mitoxantrone can induce clinical responses in adults with relapsed or refractory acute leukemias and high-risk mds 1.2 secondary objectives: * to determine the ability of pd 0332991 to directly induce apoptosis in malignant cell populations in vivo * to obtain pharmacodynamic (pd) data regarding the ability of pd 0332991 to arrest malignant cells in the g 1 phase of cell cycle, followed by synchronized release of those cells into s phase upon discontinuation of pd 0332991 and resultant enhanced ara-c cytotoxicity


Eligibility criteria:
inclusion criteria: * adults age ≥ 18 years * multilineage bone marrow failure * serum creatinine ≤ 2.0 mg/dl * hepatic enzymes (ast, alt) ≤ 3x upper limit of normal (uln) * bilirubin ≤ 2.0 mg/dl, unless due to gilbert's disease, hemolysis or leukemic infiltration * left ventricular ejection fraction ≥ 45% * qtc ≤ 470 msec * rb expression is required for the action of pd 0332991. because rb deletions and mutations are rare in acute leukemias and mds, screening for rb expression will not be required before enrollment. pretreatment biopsies will be stored and analyzed for rb expression if needed subsequently. exclusion criteria: * • no more than 5 cytotoxic regimens * previous allogeneic or autologous stem cell transplantation permitted * ≥ 3 weeks delay from prior cytotoxic chemotherapy or radiation therapy * ≥ 2 week delay from prior biologic therapies including hematopoietic growth factors and vidaza or decitabine * if using hydroxyurea, steroids, tyrosine kinase/src kinase inhibitors, arsenic, interferon for count control, must be off therapy for ≥ 48 hours prior to beginning pd 0332991 * no concomitant use of potent cyp450 3a4 inhibitors (e.g. triazole antifungal agents) or inducers (e.g. omperazole, dilantin, dexamethasone) within 7 days prior to beginning pd 0332991
clinical study to investigate the pk, efficacy, and safety of wilate in patients with severe hemophilia a

Conditions: Severe Hemophilia A

Summary: the purpose of this study is to obtain additional data on the safety and efficacy of wilate in ptps with hemophilia a with at least 150 previous exposure days (eds) to a fviii concentrate who undergo prophylactic treatment with wilate for 6 months and at least 50 eds, thus supplementing the existing database to obtain approval of wilate for the indication hemophilia a in the usa.


Eligibility criteria:
inclusion criteria: 1. severe hemophilia a (\<1% fviii:c) according to medical history 2. male patients aged ≥12 years 3. previous treatment with a fviii concentrate for at least 150 exposure days (eds) 4. immunocompetence (cd4+ count \>200/µl) 5. good documentation of the historical bleeding rate (at least for the 6 months preceding study start) 6. voluntarily given, fully informed written and signed consent obtained by the patient (or parent/legal guardian in case of adolescents) before any study-related procedures are conducted whenever possible, the interval between the screening visit and the pk or non-pk visit should not exceed 30 days. if the 30-day interval is exceeded, determination of the cd4+ count is to be repeated and must be \>200/µl for patients to be enrolled (i.e., exclusion criterion no. 4). exclusion criteria: 1. any coagulation disorders other than hemophilia a 2. history of fviii inhibitor activity (≥0.6 bu) or detectable fviii inhibitory anti-bodies (≥0.6 bu using the nijmegen modification of the bethesda assay) at screening, as determined by the central laboratory 3. severe liver or kidney diseases (alanine aminotransferase \[alat\] and aspartate transaminase \[asat\] levels \>5 times of upper limit of normal, creatinine\>120 µmol/l) 4. patients receiving or scheduled to receive immunomodulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to \>10 mg/day), or similar drugs 5. treatment with any investigational medicinal product in another interventional clinical study currently or within 4 weeks before enrollment
study of topical calcitriol in children with psoriasis

Conditions: Psoriasis

Summary: objectives: i. determine the therapeutic efficacy and safety of topical calcitriol in children with psoriasis.

protocol outline: patients apply topical calcitriol in petrolatum on a psoriatic lesion daily. patients also apply petrolatum without calcitriol to another psoriatic lesion daily. patients have both lesions photographed prior to therapy, monthly during therapy, and at the completion of therapy. lesions are assessed weekly for 1 month and then every 2 weeks while on study. blood samples are collected every 1 to 2 months and urine samples are collected every 2 weeks while on study.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of psoriasis at least 2 lesions with area at least 30-50 cm2 --prior/concurrent therapy-- no other concurrent therapy for psoriasis no concurrent calcium supplements greater than 1,000 mg/day no concurrent prednisone or other drugs affecting serum or urine calcium levels --patient characteristics-- renal: no high blood or urinary calcium levels other: not pregnant negative pregnancy test fertile patients must use effective contraception

Keywords: dermatologic disorders psoriasis rare disease
surgical outcomes using variable rod diameters in the treatment of idiopathic scoliosis

Conditions: Scoliosis

Summary: there are two rod sizes routinely used for the correction of juvenile and adolescent idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. currently there is no scientific evidence supporting the superiority of one size rod relative to the other. this study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm spinal instrumentation rods.

for the correction of juvenile and adolescent idiopathic scoliosis, companies offer and surgeons use varying rod sizes not based on scientific evidence, but because of personal preference, availability and company loyalty. to date there has been no literature evaluating the benefit or harm of one rod size versus the other. our dual-arm prospective study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm stainless steel instrumentation rods. these are both standard rods used in the community for this particular procedure, thus no additional risk exists for the patient. the results of this study will help guide surgeons in their decision making process when faced with the multitude of options offered by implant manufactures. comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for correction of juvenile and idiopathic scoliosis curves.

Eligibility criteria:
inclusion criteria: * diagnosis of juvenile or adolescent idiopathic scoliosis * anticipated spinal fusion surgery exclusion criteria: * individuals younger than 11 years and older than 18 years * individuals with scoliosis carrying additional diagnoses of illness.

Keywords: juvenile scoliosis adolescent scoliosis scoliosis management spinal fusion scoliosis instrumentation juvenile or adolescent idiopathic scoliosis
model-informed individualized treatment of anti-infective drugs in patients with spinal infections

Conditions: Infectious Diseases of Spine

Summary: the purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.


Eligibility criteria:
inclusion criteria: * patients with suspected/confirmed spinal infections who are undergoing anti-infective drug therapy. exclusion criteria: * pregnant/lactating women. * there are other factors that the researchers think are not suitable for inclusion
percutaneous translumbar vs transhepatic permcath

Conditions: End Stage Renal Disease

Summary: the aim of the study is to emphasize the technique , success rate , efficacy of translumbar and transhepatic approaches and shed light on the complications of both methods and through comparison we can give recommendations to either of these methods.

for selected esrd patients who have exhausted all conventional access routes , translumbar and transhepatic permcath provide additional sites for access. this study will compare the two methods in terms of technical success (position of catheter tip), patency (primary defined as the number of catheter days from initial placement until removal \& secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients, function (adequacy of dialysis based on urea reduction ratio urr \& simplified daugirdas formula kt/v) and complications (infectious; exit site infection \& sepsis and non-infectious; thrombosis, catheter migration, hematoma, intraperitoneal hemorrhage.

Eligibility criteria:
inclusion criteria: - chronic dialysis patients with failed classic routes of catheterization ( internal jugular, subclavian and femoral veins bilaterally ) as well as non-functioning a-v fistulas. exclusion criteria: 1. patients with uncorrectable coagulopathy. 2. patients on long term anticoagulants 3. concurrent active infection. 4. sgnificant abdominal ascites. (transhepatic) 5. cirrhotic liver disease patients. (transhepatic) 6. morbid obesity. (translumbar)
hcv microfluidic diagnostics

Conditions: Hepatitis C

Summary: hepatitis c diagnostic devices have been developed at the university of hull to detect and quantify the hepatitis c virus in patients' plasma and serum samples. this study aims to test the new point-of-care devices that are designed to be low cost and user-friendly. excess, stored, hcv patients' plasma, serum and blood samples will be supplied by the virology laboratory (hull university teaching hospital's trust; huth). these samples were taken and analysed as part of patients' clinical monitoring, and are stored prior to disposal in the virology laboratory. the proposed study will use the samples in a fully anonymised manner.


Eligibility criteria:
inclusion criteria: * blood sample taken exclusion criteria: * none
neuroimaging study of bupropion treatment in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the current study is being conducted in patients with major depression. the study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (ssri) and bupropion compared to ssri alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (mri), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.


Eligibility criteria:
inclusion criteria: * men and women aged between 20 and 65 * diagnosis of major depressive disorder (mdd) as assessed by the structured clinical interview for dsm-iv (scid-iv) * individuals who provided written consent for participation. exclusion criteria: * presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.) * diagnosis of any axis i disorder other than mdd or presence of symptoms requiring hospitalization * intelligence quotient (iq) below 80 * contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.) * unstable medical illness or other abnormalities observed at the screening or laboratory tests * women who are pregnant, breastfeeding, or planning pregnancy * allergy or tolerance to the clinical trial medication * presence of any physical illness that contraindicates the clinical trial medication (e.g., epilepsy, history of uncontrollable narrow-angle glaucoma) * use of psychoactive medications that may affect brain imaging findings
effects of scenario-based education initiative and osce for recognition and management of delirium

Conditions: Delirium

Summary: delirium is a disturbance in consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day. 50% to 81.7% had delirium during their icu hospitalization. delirium is associated with increased physical restraint, ventilation use, length of icu stay, and mortality. however, there is no established delirium care pathway in target hospital. chen et al. (2014) demonstrated that structured assessment stations with immediate feedback may improve overall learning efficiency over an ebp workshop alone. however, no published delirium care education study has used osces as an intervention for healthcare professionals. the aim is to evaluate the effects of implementing a scenario- based education intervention, including objective structured clinical examinations (osces) on delirium care among healthcare professionals. this is a knowledge translation research, builds on eight years of delirium care research in university of wollongong, australia. the research will be undertaken at icus in a medical center in northern of taiwan. there are two phases: (1) systematic review to identify delirium screen tool, and (2) a randomized controlled trial was conducted to determine the effects of implementing a scenario-based education intervention, including osce (experimental group), and on-line education only (control group) focused on recognition and management of delirium. the hypothesis is: scenario-based education intervention, including osce can increase the competence and self-efficacy among healthcare professionals in delirium care.

osces are an integral aspect of all levels of medical education but limited to undergraduate nursing and allied health education. osces are rarely used in the workplace as learning activities with nursing and allied health clinicians. this is the reason why this education initiative was innovative. osces are simulated 'real life' clinical scenarios presented to clinicians who are required to demonstrate to an assessor the clinical tasks which form an osce scenario.

Eligibility criteria:
inclusion criteria: 1. registered nurse worked in acute care unit and care with critical patients 2. licensed physician which undertake the post graduate year program worked in acute care unit and care with critical patients exclusion criteria: 1.unwilling to involved the research

Keywords: intensive care unit syndrome delirium osce
evaluation of the muscular and cutaneous sodium storage by 23na mri in patients with chronic adrenal insufficiency

Conditions: Adrenal Insufficiency

Summary: this study investigates the sodium content in the calf muscle and the skin obtained via 23na-magnetic resonance imaging in patients with chronic adrenal insufficiency compared to healthy controls.

patients with chronic adrenal insufficiency depend on lifelong glucocorticoid and mineralocorticoid replacement therapy. monitoring is based on clinical and laboratory parameters reflecting hemodynamic stability, electrolyte status and plasma renin concentration. reduced subjective well-being is however often described by these patients in absence of clinical or laboratory abnormalities and is thus a strong indicator of the gap between the concept of adequate hormone substitution and patients' requirements. this study investigates the sodium content in the calf muscle and the skin obtained via 23na-magnetic resonance imaging (mri) in patients with chronic adrenal insufficiency compared to age-, sex- and bmi- matched healthy controls. the aim of the study is to evaluate the potential role of 23na-mri for monitoring of hormone replacement by investigating tissue sodium concentrations in patients with adrenal insufficiency.

Eligibility criteria:
inclusion criteria: * age \> 18 years * written informed consent * chronic adrenal insufficiency (first diagnosis \> 6months), stable hormone replacement therapy with glucocorticoids (no dose-adjustment \>50mg hydrocortisone within the last 8 weeks) and mineralocorticoids (only primary adrenal insufficiency)! or healthy control (no adrenal insufficiency, normal serum-electrolytes, normotensive blood pressure, no medication with a known influence on the electrolyte balance)! exclusion criteria: * pregnancy or breast-feeding * metal-implant (not mri-compatible) * claustrophobia * chronic internistic disease (hypertension, heart failure, liver cirrhosis) * polydipsia (\>4l/d) * long-term medication that can cause a hyponatraemia (for example diuretics)

Keywords: hormone replacement mineralocorticoids 23na-magnetic resonance imaging tissue sodium content